FB4 (Framingham, Boston, Bloomington, Birmingham, and Baylor)

Stopped early · Not applicable

Conditions studied: Obesity

In brief

This study will evaluate the effects of dietary carbohydrate and sugar consumption, independent of energy content, on body fatness and metabolism in a rigorous feeding study.

Key facts

Study ID

NCT03394664

Run by

Boston Children's Hospital

People needed

166

Starts

2018-05-09

Expected to finish

2020-05-03

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged 18 to 50 years
• BMI ≥ 27 kg/m2
• Weight ≤ 350 lb
• Medical clearance from a primary care provider
• Willingness to follow a VLC weight-loss diet
• Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages
• No major food allergies or aversions
• Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only)
• Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase.

You may not qualify if…

• Change in body weight ≥ 10% during prior 6 months
• Specialized diets (e.g., for medical or religious reasons)
• Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine)
• Current smoking (1 cigarette in the last week)
• Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months)
• Physician diagnosis of a major medical illness or eating disorder
• History of kidney stones
• Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes)
• Failed criminal offender background check or sex offender background check
• Use of recreational drugs
• Current diagnosis or history of kidney stones, gout, or gall stones; or removal of gall bladder
• Exercise restrictions or at high risk for complications during exercise
• Female-specific exclusion criteria:
• Menopausal
• Any change in birth control medication during the 3 months prior to enrollment
• Pregnancy or lactation during the 12 months prior to enrollment, or intent to become pregnant during study participation

Where it is running

• Warren Conference Center and Inn — Ashland, Massachusetts, United States

Full record on ClinicalTrials.gov

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